Quality

All generic companies must perform “bioequivalence studies” to demonstrate that the generic medicine is equivalent to the originator reference product. The generic medicine and the originator are considered to be bioequivalent (and therefore interchangeable) when the bioequivalence study demonstrates that the two formulations have no significant differences in the rate and extent of absorption in the human body. The test involves comparing the same dose under the same conditions.

Furthermore, as in the case of all licensed medicine, a continual risk-benefit analysis is carried out for the lifetime of all generic products. Under EU regulations it is a requirement for all pharmaceutical companies to provide an appropriate system of pharmacovigilance in order to assume the responsibility and liability for their medicines. Generic companies are committed to meeting all these requirements and to ensuring that patients only receive safe and effective medicines.